FDA Compliance Service Fees
Transparent pricing for U.S. Agent services supporting prescription drug, OTC drug, and cosmetic manufacturers worldwide.
Drug Establishment Registration
Domestic and foreign establishments manufacturing, repacking, or relabeling prescription drugs, OTC drugs, and active pharmaceutical ingredients (APIs) must complete mandatory annual FDA registration and product listing. Registration renewals occur annually between October 1 and December 31. Foreign facilities must appoint or maintain a U.S. Agent.
Product Listing (NDC & SPL Submission)
FDA drug listing submission including Structured Product Labeling (SPL)
* Proprietary and established (generic) name
* Active and inactive ingredients (with strength)
* Dosage form and route of administration
* National Drug Code (NDC) number
* Labeling and package configuration
* Marketing category (OTC Monograph, NDA, ANDA)
* Manufacturer and distributor information
Label Compliance Review
Comprehensive FDA label review to ensure compliance with OTC monographs, prescription labeling rules, and cosmetic regulations, including the strict "Drug Facts" format for OTCs and proper ingredient declaration for cosmetics. Key requirements involve validating active ingredients against monographs, ensuring truthful claims, proper formatting, and mandatory warning language. For combo products, both OTC drug and cosmetic regulations apply.
Import Support
Regulatory assistance for FDA import alerts, customs clearance coordination, and detention resolution support. FDA Consultants provide crucial support to overcome FDA import alerts (DWPE) and detentions, offering services that include analyzing detention notices, developing Corrective Action Plans (CAPs), conducting facility audits, coordinating private laboratory testing, and drafting advocacy documents. These services ensure compliance with FDA regulations, manage customs clearance, and help lift import restrictions.
Inspection Readiness
Mock FDA inspections, gap assessments, and documentation reviews are proactive, risk-based strategies designed to identify compliance vulnerabilities, such as 483 observations or warning letters, before official regulatory scrutiny. These services simulate inspections (GMP, GCP, GLP) to ensure, validate, and enhance quality management systems (QMS), staff preparedness, and data integrity.
FDA 483 & Warning Letter Response
Professional services provide critical, 15-business-day turnaround support for FDA Form 483 observations and Warning Letters, ensuring compliant, technical responses that protect U.S. market access. Experts offer comprehensive root cause analysis, corrective and preventive action (CAPA) plans, and formal, audited documentation to remediate quality system deficiencies.
Suggested Reading • U.S. FDA Drug Compliance
U.S. FDA Drug Registration & Compliance Services
Planning to manufacture, export, import or market drug products in the United States? Explore our suggested reading on U.S. FDA drug requirements and regulatory support for domestic and foreign pharmaceutical companies. Learn more about establishment registration, drug listing, labeling, compliance responsibilities and ongoing regulatory obligations.
Drug Establishment Registration
Review important FDA registration responsibilities for domestic and foreign establishments manufacturing, preparing, propagating, compounding or processing drug products for the U.S. market.
Drug Listing & Product Information
Learn about FDA drug listing obligations and the importance of maintaining accurate establishment, product and regulatory information with the Agency.
OTC & Prescription Drugs
Explore regulatory considerations affecting over-the-counter medicines, prescription drug products and companies entering the United States pharmaceutical marketplace.
Foreign Manufacturers & U.S. Agent
Foreign drug establishments may have additional U.S. FDA responsibilities, including U.S. Agent communications and regulatory coordination with FDA.
Drug Labeling Compliance
Understand why compliant labeling, required statements, product identity, directions, warnings and other regulatory information are important before marketing drug products.
FDA Regulatory Consulting
Experienced FDA consultants can assist with registration, listing, document preparation, compliance reviews and other regulatory matters while your company concentrates on sales, distribution and market development.
Recommended Reading: FDA Drug Services
Simplify U.S. FDA registration and stay compliant. Dedicated support for pharmaceutical manufacturers, exporters, importers, and distributors entering the U.S. market.